Friday, September 11, 2009

New Chronic Fatigue Drug in the FDA pipeline

Written by Anthony Hardie, 91outcomes

( - A new drug for chronic fatigue syndrome -- a presumptive condition for veterans of the 1991 Gulf War -- is in the FDA pipeline and the FDA approval application is expected to be decided this fall according to recent news.

In clinical trials, Ampligen has been shown to improve cognition, exercise tolerance, neuropsychological health and overall function in people with ME/CFS; decrease activity of HHV-6 (a virus believed to be linked to ME/CFS); and decrease RNase L activity.
According to Ampligen's manufacturer, Hemispherx Biopharma Inc., more than 40,000 doses of Ampligen were given to about 500 patients in clinical trials at more than 20 U.S. clinics. One of those clinics, the Hunter-Hopkins Center, says 80% of its patients improved on Ampligen, and 50% improved significantly.
As with all drugs, there are potential side effects.

Possible side effects of Ampligen include:
  • Mild flushing
  • Tightness of the chest
  • Rapid heartbeat
  • Anxiety
  • Shortness of breath
  • Feeling hot
  • Sweating
  • Nausea
  • Liver enzyme level changes
  • Diarrhea
  • Itching
  • Low blood pressure
  • Rash
  • Arrhythmias
  • Low white blood cell count
  • Dizziness
  • Confusion
Some patients have flu-like symptoms for a few hours after receiving a dose of the drug, and the company says these effects typically went away after several months of treatment.

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